BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GU VAGINAL PERINEAL PACK

    MDR report key: 3799092 · Received May 2, 2014

    Report

    Report Number
    3799092
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    PROFESSIONAL HOSPITAL SUPPLY INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    LEGGING DRAPE HAS OPENING ON PROXIMAL PART OF THE DRAPE UPON OPENING FROM PACKAGING. PACKAGING ON SURGICAL PACK APPEARS INTACT. NO HARM TO PATIENT; DISCOVERED WHEN SETTING UP FOR CASE. ANOTHER PACK OPENED. THE DRAPE SHOULD NOT HAVE AN OPENING ON THE PROXIMAL PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263748 GU VAGINAL PERINEAL PACK GENERAL SURGERY TRAY (KIT) LRO PROFESSIONAL HOSPITAL SUPPLY INC. * 1107455

    Patients

    Seq Age Sex Outcome Treatment
    1 *